Healthcare Regulatory & Compliance

Overview

With a comprehensive understanding of healthcare regulatory requirements, our team at Nixon Peabody possesses the expertise to effectively navigate and address all aspects of regulatory issues. Our team, including two former state Department of Health (DOH) attorneys, has decades of experience in developing plans that address state and federal regulations, ensuring compliance and obtaining the necessary approvals.

We are in constant communication with our colleagues at the DOH, and our strong relationships allow for candid discussions surrounding issues or modifications required ahead of submitting applications for formal regulatory approval. We establish, implement, and monitor compliance programs that prevent, detect, and correct practices that fail to comply with the complex fraud and abuse laws governing healthcare services. And if violations do happen, we act quickly to prevent further issues, minimize penalties, and, when necessary, handle investigations and prosecutions by both federal and state entities.

Representative experience

• Provider of healthcare IT solutions: Advised in connection with fraud and abuse analysis of its operations, federal and state privacy compliance, and integrating its pharmaceutical technology products with certain EHR vendors
• Pain management services and practices: Advised in connection with guidance on Stark and kickback compliance issues surrounding physician office laboratories
• Patient assistance program: Represented in connection with day-to-day regulatory advice with respect to the federal Anti-Kickback Statute and other applicable federal healthcare regulations
• Physician practice: Counseled in connection with healthcare regulatory issues including, review and revision of acquisition agreements to address issues related to the Stark Law, Anti-Kickback Statute, and the state law equivalents of each
• Large privately held specialty health plan: Served as regulatory counsel for all compliance-related matters
• National anesthesiology services company: Represented in a False Claims Act case in the Eastern District of California
• Regional medical center: Advised in connection with an internal audit of its skilled nursing facility’s compliance with physician certification regulations and an internal audit related to their home health agency’s compliance with Medicare conditions of payment
• Community hospital: Represented in a joint investigation by the U.S. Attorney’s Office for the Eastern District of New York and the New York Attorney General’s Office involving alleged False Claims Act violations involving Medicare and Medicaid billing matters
• National hospice company: Represented in a federal investigation by the U.S. Department of Justice and six separate U.S. Attorney’s Offices throughout the country alleging False Claims Act violations relating to Medicare reimbursement for purportedly ineligible hospice patients
• Represented a variety of telehealth and diagnostic platforms, from startups to fully operational, in connection with regulatory and compliance issues relating to state-specific telemedicine requirements, novel COVID-19 testing rollouts, and provision of services through a virtual platform

Recognition

• Named as a leading firm in Healthcare by Chambers USA in 2021; 31 healthcare lawyers ranked
• Ranked Tier 1 nationally for Healthcare Law by U.S. News—Best Lawyers “Best Law Firms” in 2021 and in consecutive years prior; named “Law Firm of the Year” in Healthcare Law by U.S. News—Best Lawyers “Best Law Firms” in 2016; 31 healthcare lawyers ranked 
• Recognized as a top law firm in Healthcare by the American Bar Association’s Health Law Section
• Ranked nationally as one of the largest healthcare firms by Modern Healthcare